Ensuring Patient Access to Critical Breakthrough Products Act
- Sponsor
- Rep. Moore, Blake D. [R-UT-1]
- Committees
- Ways and Means Committee (primary)
- Last action
- Sep 17, 2025
Bottom line
The bill aims to accelerate Medicare beneficiary access to innovative medical devices by guaranteeing temporary coverage and streamlining the permanent coverage determination process, while providing dedicated funding for administrative oversight.
What it actually does
This bill establishes a new pathway for Medicare coverage of "breakthrough devices" by creating a mandatory 4-year transitional coverage period for devices designated as breakthrough by the Secretary of Health and Human Services. It sets specific criteria for such designation, including FDA priority review and clinical data involving Medicare beneficiaries, and requires a National Coverage Determination process to be completed before the transitional period ends. The bill also appropriates funds for the Centers for Medicare & Medicaid Services (CMS) to manage these new processes.
Proponents argue
Supporters argue that this bill addresses a critical gap in Medicare coverage for cutting-edge medical devices, ensuring that beneficiaries can access life-saving and life-improving technologies more quickly. They contend that the current coverage process is too slow, delaying patient access and stifling innovation, and that a guaranteed transitional coverage period will incentivize device manufacturers to develop products for the Medicare population.
Opponents contend
Critics might argue that mandating coverage for breakthrough devices, even temporarily, could lead to increased Medicare spending without sufficient evidence of long-term efficacy or cost-effectiveness. Concerns could also be raised about the potential for devices to be covered that later prove to have limited benefit or unforeseen risks, despite the FDA review and risk assessment criteria included in the bill.
The bill is concise and relatively easy to read, allowing an informed reader to grasp its core provisions within the typical time allotted for legislative review.
Section 2(a)(1), amending 1862(a)(1) of the Social Security Act
Establishes 4-Year Transitional Medicare Coverage for Breakthrough Devices
This provision mandates that Medicare will cover "breakthrough devices" for a period of four years, starting from the date they are designated as such by the Secretary. This coverage is guaranteed unless the device is used outside its FDA-approved label for diagnosis or treatment, or if the Secretary determines it poses an undue risk of harm that outweighs its potential benefits for Medicare beneficiaries.
Supporters argue
Proponents argue this ensures timely access for Medicare patients to cutting-edge medical devices that have already received expedited review from the FDA, preventing delays that can harm patient outcomes and stifle innovation.
Critics contend
Opponents might argue that mandating coverage before a full National Coverage Determination is complete could lead to Medicare paying for devices whose long-term clinical benefits or cost-effectiveness are not yet fully established, potentially increasing costs and risks for beneficiaries.
Tradeoffs
Balances the desire for rapid patient access to innovation against the need for thorough evaluation of efficacy, safety, and cost-effectiveness before permanent coverage.
Section 2(a)(2), amending 1861 of the Social Security Act
Defines "Breakthrough Device" and "Transitional Coverage Period"
This section formally defines a "breakthrough device" as one designated by the Secretary under a new section (1899D) and furnished according to its FDA-approved label frequency. It also establishes the "transitional coverage period" as a fixed four-year duration beginning on the date of the Secretary's designation.
Section 2(a)(3), adding new Section 1899D to Title XVIII of the Social Security Act
Establishes Criteria and Process for Secretary's Designation of Breakthrough Devices
This new section outlines the conditions a device must meet to be designated as a "breakthrough device" by the Secretary, including receiving FDA priority review, being cleared based on clinical data involving Medicare beneficiaries (if applicable), and not presenting an undue risk. It also sets a 6-month deadline for the Secretary to make a determination on applications and requires an explanation if a device is not designated. Annual reports to Congress on designation activity are also mandated.
Section 2(b), amending 1862(l)(2) of the Social Security Act
Mandates Timely National Coverage Determinations for Breakthrough Devices
This provision requires the Secretary to ensure that a final National Coverage Determination (NCD) for a breakthrough device is made before the end of its 4-year transitional coverage period. This is contingent on the NCD request being submitted at least 9 months (or 12 months for certain requests) before the end of that period.
Section 2(c)
Appropriates Funds for Program Management
This section appropriates $10,000,000 annually for fiscal years 2025 through 2030 to the Centers for Medicare & Medicaid Services (CMS) Program Management Account. These funds are designated to carry out the amendments made by this Act and remain available until expended.
The bill specifies conditions under which transitional coverage for a breakthrough device would NOT be provided: if it's not furnished for diagnosis/treatment/improvement in accordance with FDA-approved labeling for the priority review indication, or if the Secretary finds it presents an undue risk of harm outweighing potential clinical benefits for Medicare beneficiaries.
Section 2(a)(1)(Q)
Why it matters:This is standard legislative drafting for specifying exceptions and limitations to a general rule, ensuring necessary guardrails are in place.
Case for: Supporters would argue this provides crucial guardrails, preventing coverage for off-label uses or devices that prove to be harmful, thereby protecting both beneficiaries and the Medicare program's integrity.
Case against: Critics might argue that the "undue risk of harm" clause gives the Secretary too much discretion to deny coverage, potentially undermining the intent of guaranteed transitional coverage for breakthrough devices.
Estimated impact: Limits the scope of mandatory coverage, potentially affecting a small number of devices or specific uses, ensuring patient safety and program integrity.
The new process for designating breakthrough devices, which triggers the 4-year transitional coverage, will not begin until 18 months after the date of the bill's enactment.
Section 2(a)(3), new Section 1899D(a)
Why it matters:This is standard legislative practice to allow federal agencies sufficient time to prepare for the implementation of new programs, including developing regulations, hiring staff, and setting up administrative systems.
Case for: Supporters would argue this 18-month delay is a practical necessity, giving CMS sufficient time to establish the new designation process, develop regulations, and allocate resources before the program goes live, ensuring a smooth rollout.
Case against: Patient advocates might argue that any delay in access to breakthrough devices is detrimental, especially for patients with urgent medical needs, and that CMS should be able to implement such a critical program faster.
Estimated impact: Delays the start of the new coverage pathway by 1.5 years, meaning Medicare beneficiaries will not gain expedited access to breakthrough devices until this period has passed.